Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifam
FDA device recall Z-0733-2017 · posted 2016-12-12 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- Reason for recall
- Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
- Action taken
- Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at fieldactionsna@cookmedical.com. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 99 units
- Distribution
- AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
- Date initiated
- 2016-11-28
- Date posted
- 2016-12-12
- Date terminated
- 2017-09-06
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING (K033843) | Cook, Inc. | 2004-08-12 |